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非侵入式血壓計檢測項目報價???解決方案???檢測周期???樣品要求? |
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本標(biāo)準(zhǔn)規(guī)范使用充氣式壓脈帶作非侵入式動脈血壓量測的電子或自動血壓計(以下簡稱血壓計)和其配件的一般、性能、效益、機(jī)械和電性安全規(guī)定,包括型式認(rèn)證之測試方法壓脈帶。本標(biāo)準(zhǔn)僅適用于量測上臂、手腕或大腿之器材。
本標(biāo)準(zhǔn)規(guī)范非侵入式血壓計及其配件的一般規(guī)定,此血壓計藉由可膨脹的壓脈帶作動脈血壓之非侵入式量測。本標(biāo)準(zhǔn)規(guī)范這些裝置之性能、效益、機(jī)械性與電性安全的規(guī)定及測試方法。
本標(biāo)準(zhǔn)連同CNS 15041-1〔非侵入式血壓計-第1部:一般規(guī)定〕規(guī)范非侵入式機(jī)械式血壓計及其配件之性能、效益、機(jī)械性與電性安全的規(guī)定及測試方法。此血壓計藉由可膨脹的壓脈帶作動脈血壓之非侵入式量測。
本標(biāo)準(zhǔn)規(guī)范機(jī)電式血壓量測系統(tǒng)的性能、效益及安全性規(guī)定,此系統(tǒng)藉由可膨脹的壓脈帶在上臂、腕部及腿部作動脈血壓之非侵入性量測。本標(biāo)準(zhǔn)亦規(guī)范系統(tǒng)之配件的規(guī)定及測試方法。本標(biāo)準(zhǔn)適
This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11,and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressuremeasurement by operator observation.This part of ISO 81060 specifies requirements for the safety and essential performance, includingeffectiveness and labelling, for non-automated sphygmomanometers and their accessories, including testmethods to determine the accuracy of non-invasive blood pressure measurement.The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensingelement and display used in conjunction with means of detecting blood flow.EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods.Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressuresensing elements and/or displays used in conjunction with other automatic methods determining bloodpressure are specified in IEC 60601-2-30 [7].Requirements for invasive blood pressure measurement equipment that directly measure blood pressure arespecified in document IEC 60601-2-34 [8].EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement ofcirculatory system pressures.
This part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure atThe upper arm,The wrist andThe thigh. It also specifies requirements forTheir accessories and gives test methods.This part of EN 1060 applies to electro-mechanical blood pressure measuring systems in whichThe cuff pressure is measured electronically, but in whichThe blood pressure can be determined either manually withThe aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995.This part of EN 1060 is to be used in conjunction with EN 1060-1.
This part of I SO 81060 specifies r equirements f or non-automated sphygmomanometers, as defined in 3.11,and their a ccessories, which, by m eans o f inflatable cuffs, a re u sed for the non-invasive blood pressuremeasurement by operator observation.
La présente partie de l'ISO 81060 spécifie les exigences relatives aux sphygmomanomètres non automatiques tels que définis en 3.11 et à leurs accessoires qui, à l'aide d'un brassard gonflable, sont utilisés pour le mesurage non invasif de la pression artérielle par le biais de l'observation d'un opérateur.La présente partie de l'ISO 81060 spécifie les exigences relatives à la sécurité, aux performances essentielles, à l'efficacité et au marquage des sphygmomanomètres non automatiques et de leurs accessoires, y compris les méthodes d'essai destinées à déterminer l'exactitude de mesure non invasive de la pression artérielle. La présente partie de l'ISO 81060 traite des dispositifs de mesure non invasive de la pression artérielle équipés d'un élément détecteur de pression et d'un affichage utilisés conjointement afin de déterminer le flux sanguin.Les exigences relatives aux appareils de mesure non invasive de la pression artérielle à l'aide d'éléments détecteurs de pression électriques et/ou d'affichages utilisés conjointement avec d'autres méthodes automatiques de détermination de la pression artérielle sont spécifiées dans la IEC 60601-2-30. Les exigences relatives aux appareils de mesure invasifs de la pression artérielle destinés à mesurer directement la pression artérielle sont spécifiées dans la IEC 60601-2-34.
Specifies general requirements for non-invasive sphygmomanometers and their accessories. .
Specifies performance, efficiency and mechanical and electrical safety requirement, including test methods, fornon-invasive mechanical sphygmomanometers and their accessories. .